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Clinical Trials/NCT03797742
NCT03797742
Unknown
N/A

A Clinical Follow-up Study of Heart Failure Patients.

Shanghai Zhongshan Hospital1 site in 1 country500 target enrollmentJanuary 1, 2018
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Shanghai Zhongshan Hospital
Enrollment
500
Locations
1
Primary Endpoint
NYHA functional class
Last Updated
7 years ago

Overview

Brief Summary

Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 1, 2022
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • LVEF≤ 55%
  • enlarged left ventricular end-diastolic dimension
  • ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
  • symptomatic heart failure

Exclusion Criteria

  • Known malignant tumour diseases
  • Pregnancy or lactation period;
  • Investigators think not suitable to participate in this trial.

Outcomes

Primary Outcomes

NYHA functional class

Time Frame: one year after enrolled

NYHA cardiac functional class

All-cause mortality

Time Frame: one year after enrolled

All-cause mortality during follow-up

Secondary Outcomes

  • left ventricular end-diastolic dimension(LVEDD) dilates.(one year after enrolled)
  • left ventricular ejection fraction reduces(one year after enrolled)
  • hospitalization for cardiac causes(one year after enrolled)

Study Sites (1)

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